Court of Appeals ruled commercial success does not constitute substantial evidence of drug safety and efficacy
On Feb. 27, 1970, in Upjohn v. Finch the Court of Appeals upheld enforcement of the 1962 drug…
FDA required the first patient package insert: oral contraceptives must contain information for the patient about specific risks and benefits
In 1970, the FDA required the first patient package insert: oral contraceptives must contain information for the patient…
Charles Edwards, MD, became FDA commissioner
On Dec. 13, 1969, Charles Edwards, M.D., becomes FDA commissioner.
The White House Conference on Food, Nutrition, and Health recommended systematic review of GRAS substances
On Dec. 2, 1969, the White House Conference on Food, Nutrition, and Health recommended systematic review of GRAS…
FDA issued report that declared birth control pills “safe”
On Sept. 4, 1969, the FDA issued a report that called birth control pills safe, despite a slight…
FDA began administering Sanitation Programs for milk, shellfish, food service, and interstate travel facilities
In 1969, the FDA began administering Sanitation Programs for milk, shellfish, food service, and interstate travel facilities, and…
A second live, further attenuated measles virus vaccine was licensed
On Nov. 26, 1968, the U.S. Food and Drug Administration (FDA) licensed a second live, further attenuated measles…
FDA Bureau of Drug Abuse Control and Treasury Department Bureau of Narcotics were transferred to Dept of Justice
On Apr. 7, 1968, the FDA Bureau of Drug Abuse Control and Treasury Department Bureau of Narcotics were…
Reorganization of federal health programs placed FDA in the Public Health Service
In March 1968, a reorganization of federal health programs placed the U.S. Food and Drug Administration (FDA) in…
FDA formed the Drug Efficacy Study Implementation
In 1968, The FDA formed the Drug Efficacy Study Implementation (DESI) to implement recommendations of the National Academy…
Medtronic annual sales skyrocketed to more than $12 million
In 1968, Medtronic annual sales skyrocketed to more than $12 million, with the company reporting net income in…
Mumps virus vaccine live (MumpsVax by Merck) was licensed
On Dec. 28, 1967, the U.S. Food and Drug Administration (FDA) approved Mercks mumps virus vaccine live (MumpsVax)….
Medtronic introduced two “on-demand” pacemakers
In 1967, Medtronic introduced two “on-demand” pacemakers, designed to avoid competition between paced beats and the patient’s own…
The Child Protection Act was passed by the US.. Congress
On Nov. 3, 1966, the Child Protection Act was passed by the U.S. Congress. The bill enlarged the…
FDA appointed science advisors to stimulate career development
On Jun. 8, 1965, FDA appointed science advisors to stimulate career development.
Fair Packaging and Labeling Act required all consumer products in interstate commerce to be honestly and informatively labeled
In 1966, the Fair Packaging and Labeling Act required all consumer products in interstate commerce to be honestly…
The FDA licensed amantadine, a new antiviral medication, as a prophylactic against influenza A
In 1966, the U.S. Food and Drug Administration (FDA) licensed amantadine (marketed as Symmetrel) to Du Pont, a…
FDA requested help in removing “X-33 Water Repellent” from the market
On Aug. 30, 1964, the U.S. Food and Drug Administration (FDA) requested help in removing “X-33 Water Repellent”…
The anticancer drug Azidothymidine (AZT) was synthesized in Michigan Cancer Foundation’s chemistry lab
In 1964, the anticancer drug Azidothymidine (AZT) was synthesized in Michigan Cancer Foundationﾒs chemistry lab by Jerome Horwitz,…
The U.S. FDA approved vincristine, a sister drug to vinblastine
On Jul. 10, 1963, the U.S. FDA approved vincristine, a sister drug to vinblastine. The drug was established…
FDA issued regulations to implement the Kefauver-Harris drug amendments
On Jun. 20, 1963, the FDA announced three sets of regulations governing“ the manufacture, effectiveness and promotion of…
Jere E Goyan, PhD, became commissioner of food and drugs
On Oct. 21, 1962, Jere E. Goyan, Ph.D., becomes commissioner of food and drugs. Goyan was the first…
The Kefauver-Harris Drug Amendments were signed into law
On Oct. 10, 1962, the Kefauver-Harris Drug Amendments were signed into law by President Kennedy. The Legislation was…
Thalidomide-caused birth defects lead to strengthened drug regulation
On Jul. 15, 1962, Thalidomide, a new sleeping pill developed by the German company Gr�nenthal, was found to…
The National Congress on Medical Quackery convened in Washington, DC
On Oct. 6, 1961, the National Congress on Medical Quackery convened in Washington, D.C. sponsored jointly by the…
Congress authorized the SEC to conduct a study of fragmentation in the OTC market
In September 1961, U. S. Congress authorized the Securities and Exchange Commission (SEC) to conduct a study of…
External D & C No 15 cleared for uses outside the body
On Jan. 10, 1961, External D&C No. 15, a red color additive widely used in cosmetics before it…
Last remaining source of the Hoxsey cancer treatment was eliminated by a federal court order
On Sept. 21, 1960, FDA officials announced the last remaining major source of the discredited Hoxsey cancer treatment…
Federal Hazardous Substances Labeling Act required prominent label warnings on hazardous household chemical products
On Jul. 12, 1960, the President approved the Federal Hazardous Substances Labeling Act, enforced by FDA, which required…
The FDA approved Enovid as the first oral contraceptive available in the US
In 1960, The FDA approved Enovid as the first oral contraceptive available in the U.S.